Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The SolidStateMC is an AEC-sensor. (AEC=Automatic Exposure Control) This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
13594-10
In Commercial Distribution

  • 08718755001013 ()


  • Solid-state-semiconductor radiation measuring probe
The SolidStateMC is an AEC-sensor. (AEC=Automatic Exposure Control) This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
12851-10
In Commercial Distribution

  • 08718755001006 ()


  • Solid-state-semiconductor radiation measuring probe
The SolidStateMC is an AEC-sensor. (AEC=Automatic Exposure Control) This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
12838-10
In Commercial Distribution

  • 08718755000993 ()


  • Solid-state-semiconductor radiation measuring probe
Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowable resin. (A2-A2-A3-A3-A3.5)
Meta Biomed Co., Ltd.
9499
In Commercial Distribution

  • 08806387894995 ()


  • Dental composite resin
Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowable resin. (A1-A1-A2-A2-A3)
Meta Biomed Co., Ltd.
9498
In Commercial Distribution

  • 08806387894988 ()


  • Dental composite resin
Metapex is a paste type root canal filling material. It is consist of Calcium Hydroxide with lodoform.
Meta Biomed Co., Ltd.
9325
In Commercial Distribution

  • 08806387893257 ()


  • Endodontic temporary cement
Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowable resin. (A2-A3-A3.5-B2-B3)
Meta Biomed Co., Ltd.
6001
In Commercial Distribution

  • 08806387860013 ()


  • Dental composite resin
Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowable resin. (A2-A3-A3-A3.5-A3.5)
Meta Biomed Co., Ltd.
6000
In Commercial Distribution

  • 08806387860006 ()


  • Dental composite resin
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF003
In Commercial Distribution

  • 00850013007417 ()
ELF003

  • Audiometric/hearing device software
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF001
Not in Commercial Distribution

  • 00850013007042 ()
ELF001

  • Audiometric/hearing device software
SmartLite Focus Power Connector is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450050
In Commercial Distribution

  • D010644500501 ()

  • Length: 7.5 Centimeter
64450050

  • Dental/surgical polymerization lamp
SmartLite Focus Battery Pack is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450021
In Commercial Distribution

  • D010644500211 ()

  • Length: 5.9 Centimeter
64450021

  • Dental/surgical polymerization lamp
Light. This is sold as part of the 11-Unit Package (688203) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
In Commercial Distribution

  • D0019882980 ()

  • Weight: 231 Gram


  • Dental appliance fabrication material, resin
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Trial Size. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-12
In Commercial Distribution

  • D801ID6512I1 ()
65-12

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Carpule.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 67-02
In Commercial Distribution

  • D801SP67021 ()
67-02

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Trial Syringe.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-12
In Commercial Distribution

  • D801SP65121 ()
65-12

  • Dentine adhesive
The axial compression clamp is used to allow a compression and is used with the 115425ND K-Wire.
NEWDEAL
219900ND
In Commercial Distribution

  • M248219900ND1 ()
  • 10381780051893 ()


  • Bone holding forceps
The SURFIX® compressor is used for closing the resected angle when a closing osteotomy is implemented
NEWDEAL
MA043ND
In Commercial Distribution

  • M248MA043ND1 ()
  • 10381780044666 ()


  • Surgical flat-nosed pliers
The nut is made from stainless steel and is used to secure the strut into the ring.
Ascension Orthopedics, Inc.
12224255
In Commercial Distribution

  • 10381780125266 ()

  • 10 mm hex x 5 mm H
12224255

  • External orthopaedic fixation system, reusable
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2822020
In Commercial Distribution

  • 10381780119081 ()
  • M26828220201 ()

  • 20 mm L x 2.2 mm dia
2822020

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2822018
In Commercial Distribution

  • 10381780119074 ()
  • M26828220181 ()

  • 18 mm L x 2.2 mm dia
2822018

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2822016
In Commercial Distribution

  • 10381780119067 ()
  • M26828220161 ()

  • 16 mm L x 2.2 mm dia
2822016

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2822014
In Commercial Distribution

  • 10381780119050 ()
  • M26828220141 ()

  • 14 mm L x 2.2 mm dia
2822014

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2822012
In Commercial Distribution

  • 10381780119043 ()
  • M26828220121 ()

  • 12 mm L x 2.2 mm dia
2822012

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2822010
In Commercial Distribution

  • 10381780119036 ()
  • M26828220101 ()

  • 10 mm L x 2.2 mm dia
2822010

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2822008
In Commercial Distribution

  • 10381780119029 ()
  • M26828220081 ()

  • 8 mm L x 2.2 mm dia
2822008

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2822006
In Commercial Distribution

  • 10381780119012 ()
  • M26828220061 ()

  • 6 mm L x 2.2 mm dia
2822006

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835050
In Commercial Distribution

  • 10381780118848 ()
  • M26828350501 ()

  • 50 mm L x 2.7 mm dia
2835050

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835045
In Commercial Distribution

  • 10381780118831 ()
  • M26828350451 ()

  • 45 mm L x 2.7 mm dia
2835045

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835040
In Commercial Distribution

  • 10381780118824 ()
  • M26828350401 ()

  • 40 mm L x 2.7 mm dia
2835040

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835035
In Commercial Distribution

  • 10381780118817 ()
  • M26828350351 ()

  • 35 mm L x 2.7 mm dia
2835035

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835030
In Commercial Distribution

  • 10381780118800 ()
  • M26828350301 ()

  • 30 mm L x 2.7 mm dia
2835030

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835028
In Commercial Distribution

  • 10381780118794 ()
  • M26828350281 ()

  • 28 mm L x 2.7 mm dia
2835028

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835026
In Commercial Distribution

  • 10381780118787 ()
  • M26828350261 ()

  • 26 mm L x 2.7 mm dia
2835026

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835024
In Commercial Distribution

  • 10381780118770 ()
  • M26828350241 ()

  • 24 mm L x 2.7 mm dia
2835024

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835022
In Commercial Distribution

  • 10381780118763 ()
  • M26828350221 ()

  • 22 mm L x 2.7 mm dia
2835022

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835020
In Commercial Distribution

  • 10381780118756 ()
  • M26828350201 ()

  • 20 mm L x 2.7 mm dia
2835020

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835018
In Commercial Distribution

  • 10381780118749 ()
  • M26828350181 ()

  • 18 mm L x 2.7 mm dia
2835018

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835016
In Commercial Distribution

  • 10381780118732 ()
  • M26828350161 ()

  • 16 mm L x 2.7 mm dia
2835016

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835014
In Commercial Distribution

  • 10381780118725 ()
  • M26828350141 ()

  • 14 mm L x 2.7 mm dia
2835014

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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